Medical Devices

July 2016 510(k) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD July 2016


DEVICE: Dakin's Skin and Wound Cleanser
CENTURY PHARMACEUTICALS, INC.     510(k) NO: K150208(Traditional)
ATTN: Stephen  Deardorff          PHONE NO : 1 317 8494210 
10377 HAGUE RD.                   SE DECISION MADE: 21-JUL-16
INDIANAPOLIS IN  46256            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sheath Introducer
BIOTEQUE CORP.                    510(k) NO: K150932(Traditional)
ATTN: Simon  Lin                  PHONE NO : 886 2 25710269 
5 F-6, NO. 23, SEC. 1 CHANG-AN E. SE DECISION MADE: 22-JUL-16
TAIPEI  TW 104                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: The Progressive Orthopaedic Total Hip System
The Progressive Orthopaedic Compan510(k) NO: K151424(Traditional)
ATTN: Scott  Keiser               PHONE NO : 561 4404460 
801 US Highway 1, Suite B         SE DECISION MADE: 27-JUL-16
North Palm Beach FL  33408        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ET III Bio-SA Fixture System
HiOSSEN Inc.                      510(k) NO: K151626(Traditional)
ATTN: David  Kim                  PHONE NO : 267 759 7031 
85 Ben Fairless Dr.               SE DECISION MADE: 21-JUL-16
Fairless Hills PA  19030          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PMT Platinum Depthalon Depth Electrode
PMT CORPORATION                   510(k) NO: K151790(Traditional)
ATTN: KIM  SCHMELZER              PHONE NO : 1 952 4700866 
1500 PARK RD                      SE DECISION MADE: 14-JUL-16
CHANHASSEN MN  55317              510(k) STATEMENT
                                                    

DEVICE: BD U-500 INSULIN SYRINGE
BECTON, DICKINSON AND COMPANY     510(k) NO: K151870(Traditional)
ATTN: LUISA F. METRIO             PHONE NO : 201 8474739 
1 BECTON DRIVE                    SE DECISION MADE: 08-JUL-16
FRANKLIN LAKES NJ  07666          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit Control
EDAN INSTRUMENTS, INC.            510(k) NO: K151978(Traditional)
ATTN: TRACY  YUE                  PHONE NO : 86 755 26856469 
3/F-B, NANSHAN MEDICAL EQUIPMENTS SE DECISION MADE: 15-JUL-16
SHENZHEN  CN 518067               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HeatLux Pro II
HOME SKINOVATIONS LTD.            510(k) NO: K152087(Traditional)
ATTN: Ahava  Stein                PHONE NO : 972 4 9097470 
Tabor Building, Shaar Yokneam     SE DECISION MADE: 29-JUL-16
Yoqneam Iillit  IL 2069200        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Genesys Spine Apache® Anchored Cervical Interbody Fusion System
GENESYS SPINE                     510(k) NO: K152099(Traditional)
ATTN: BEN  KELLER                 PHONE NO : 512 3817073 
1250 CAPITAL OF TEXAS HWY BUILDINGSE DECISION MADE: 28-JUL-16
AUSTIN TX  78746                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BioHPP - breCAM.BioHPP
Bredent GmbH & Co.KG              510(k) NO: K152113(Traditional)
ATTN: Stefanie  Bochtler          PHONE NO : 49 07309 8720 
Weissenhorner Strasse 2           SE DECISION MADE: 21-JUL-16
Senden  DE 89250                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: JSM Insulin Pen Needle
JEESUNG MEDICAL CO LTD            510(k) NO: K152166(Traditional)
ATTN: CHOI YONG   HYUN            PHONE NO : 82 42 9326061 
54, MUJINI 1-GIL, DAEDEOK-GU      SE DECISION MADE: 11-JUL-16
DAEJEON  KR                       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EVOTECH ECR
Advanced Sterilization Products (A510(k) NO: K152189(Traditional)
ATTN: Nazanin   Yacobi            PHONE NO : 949 7898672 
33 Technology Dr                  SE DECISION MADE: 20-JUL-16
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FDR Visionary Suite
SHIMADZU CORPORATION              510(k) NO: K152294(Traditional)
ATTN: TOSHIO  KADOWAKI            PHONE NO : 81 75 8231305 
1 NISHINOKYO-KUWABARACHO NAKAGYO-KSE DECISION MADE: 15-JUL-16
KYOTO  JP 604-8511                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Zeramex P6 Dental Implant System
DENTALPOINT AG                    510(k) NO: K152385(Traditional)
ATTN: Viktor  Lienhard            PHONE NO : 41 443 883636 
Hohlstrasse 614                   SE DECISION MADE: 27-JUL-16
Zurich  CH 8048                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: The Time Machine Series Lasers
MEDICAL LASERS MANUFACTURER INC.  510(k) NO: K152461(Traditional)
ATTN: BRUCE   SCHOENGOOD          PHONE NO : 732 7868044 
4400 ROUTE 9 SOUTH, SUITE 1000    SE DECISION MADE: 08-JUL-16
FREEHOLD NJ  07728                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/ cannula w/ Handle, Trocar for outersheath/ cannula
PROSURG, INC                      510(k) NO: K152511(Traditional)
ATTN: ASHVIN  DESAI               PHONE NO : 408 9454044 
2193 TRADE ZONE BLVD              SE DECISION MADE: 11-JUL-16
SAN JOSE CA  95131                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Gemini Sterilization Wrap
MEDLINE INDUSTRIES, INC.          510(k) NO: K152564(Traditional)
ATTN: Jennifer  Mason             PHONE NO : 847 6433652 
ONE MEDLINE PLACE                 SE DECISION MADE: 07-JUL-16
MUNDELEIN IL  60060               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood Glucose Monitoring System
OK BIOTECH CO., LTD.              510(k) NO: K152599(Traditional)
ATTN: KE-MIN  JEN                 PHONE NO : 886 3 5160258 
NO. 91, SEC. 2, GONGDAO 5TH ROAD  SE DECISION MADE: 20-JUL-16
HSINCHU CITY  TW 30070            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Alta ACDF System
BIOMET SPINE                      510(k) NO: K152622(Traditional)
ATTN: ALEXANDRA  BECK             PHONE NO : 303 5018397 
310 INTERLOCKEN PARKWAY, SUITE 120SE DECISION MADE: 08-JUL-16
BROOMFIELD CO  80021              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pulse H20h!
TOASTER LABS, INC                 510(k) NO: K152628(Traditional)
ATTN: AMY C. BUCKALTER            PHONE NO : 206 9108332 
2212 QUEEN ANNE AVENUE NORTH, #269SE DECISION MADE: 11-JUL-16
SEATTLE WA  98109                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pulse Aloe-ahh
TOASTER LABS, INC                 510(k) NO: K152671(Traditional)
ATTN: AMY C. BUCKALTER            PHONE NO : 206 9108332 
2212 QUEEN ANNE AVENUE NORTH, #269SE DECISION MADE: 11-JUL-16
SEATTLE WA  98109                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PlasmaBlade TnA Tonsil and Adenoid Dissection Device 
MEDTRONIC ADVANCED ENERGY         510(k) NO: K152703(Traditional)
ATTN: LYDIA  SAKAKEENY            PHONE NO : 603 2945482 
180 INTERNATIONAL DRIVE           SE DECISION MADE: 08-JUL-16
PORTSMOUTH NH  03801              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: XP1100 RF
BTL INDUSTRIES, INC               510(k) NO: K152731(Traditional)
ATTN: JAN  ZARSKY                 PHONE NO : 866 2851656 
47 Loring Drive                   SE DECISION MADE: 20-JUL-16
Framingham MA  01702              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EXACTECH GPS
BLUE ORTHO                        510(k) NO: K152764(Traditional)
ATTN: ANTHONY  BOYER              PHONE NO : 33 476 549546 
5 AVENUE DU GRAND SABLON          SE DECISION MADE: 13-JUL-16
LA TRONCHE  FR 38700              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ST Internal Fixture System
T-PLUS IMPLANT TECH. CO., LTD.    510(k) NO: K152787(Traditional)
ATTN: DANA  CHENG                 PHONE NO : 866 2 22981950 
NO. 41, WUQUAN 6TH RD.. WUGU DIST.SE DECISION MADE: 22-JUL-16
NEW TAIPEI CITY  TW 24889         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SUNGSHIM STERILE SINGLE USE INSULIN SYRINGE
SUNG SHIM MEDICARE CO., LTD.      510(k) NO: K152803(Traditional)
ATTN: KIM YOUNG KWAN              PHONE NO : 82 326 767066 
190, MAESIL-RO SOJEONG-MYEON      SE DECISION MADE: 12-JUL-16
SEJONG-SI  KR 30002               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ARC InstaTemp Non-Touch Thermometer, ARC InstaTemp MD Non-Touch Thermometer
ARC DEVICES LIMITED               510(k) NO: K152905(Traditional)
ATTN: GARY  BROGAN                PHONE NO : 353 91 653155 
2 DEERPARK INDUSTRIAL ESTATE, ORANSE DECISION MADE: 20-JUL-16
GALWAY  IE H91 D72H               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle 
CREGANNA MEDICAL ASLO BUSINESS AS 510(k) NO: K152913(Traditional)
ATTN: ORLA  HICKEY                PHONE NO : 353 91 783469 
PARKMORE WEST                     SE DECISION MADE: 21-JUL-16
GALWAY   IE                       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Savannah-T® Pedicle Screw System
AMENDIA, INC.                     510(k) NO: K152920(Traditional)
ATTN: KRISTEN  ALLEN              PHONE NO : 877 7553329 
1755 WEST OAK PARKWAY             SE DECISION MADE: 08-JUL-16
MARIETTA GA  30062                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: E-Cath
PAJUNK GmbH Medizintechnologie    510(k) NO: K152952(Traditional)
ATTN: Christian G.H. Quass        PHONE NO : 49 077 049291586 
Karl-Hall-Str. 1                  SE DECISION MADE: 13-JUL-16
Geisingen  DE 78187               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ELAN 4 Motor System 
AESCULAP, INC.                    510(k) NO: K152960(Traditional)
ATTN: PETER  STOLL                PHONE NO : 610 7979300 
3773 CORPORATE PARKWAY            SE DECISION MADE: 22-JUL-16
CENTER VALLEY PA  18034           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hudson RCI AquaPak Sterile Prefilled Nebulizers
Teleflex Medical, Inc.            510(k) NO: K153010(Traditional)
ATTN: Brian  Gall                 PHONE NO : 919 5448000 682514
3015 Carrington Mill Blvd         SE DECISION MADE: 26-JUL-16
Morrisville NC  27560             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Voyant Fine Fusion
APPLIED MEDICAL RESOURCES         510(k) NO: K153017(Traditional)
ATTN: JESSICA  CHO                PHONE NO : 949 7137958 
22872 AVENIDA EMPRESA             SE DECISION MADE: 06-JUL-16
RANCHO SANTA MARGARITA CA  92688  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AcceleDent Aura
ORTHOACCEL TECHNOLOGIES, INC.     510(k) NO: K153048(Traditional)
ATTN: Zaffer  Syed                PHONE NO : 832 8030339 
6575 WEST LOOP SOUTH, SUITE 200   SE DECISION MADE: 08-JUL-16
BELLAIRE TX  77401                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ACE Electrosurgical Resection and Vaporization Electrodes Series
Ace Medical Devices Pvt. Ltd.     510(k) NO: K153055(Traditional)
ATTN: Vikas  Sethi                PHONE NO : 91 20 26681483 
E-1/7, Neptune Society Kalyani NagSE DECISION MADE: 11-JUL-16
Pune  IN 411006                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tubli-Seal, Tubli-Seal EWT,Tubli-Seal Xpress, Tubli-Seal EWT Xpress
SYBRON DENTAL SPECIALTIES         510(k) NO: K153067(Traditional)
ATTN: Courtney  Clark             PHONE NO : 714 5167634 
1717 W. COLLINS AVENUE            SE DECISION MADE: 27-JUL-16
ORANGE CA  92867                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Watch-PAT200U
ITAMAR MEDICAL, LTD.              510(k) NO: K153070(Traditional)
ATTN: KOBY  SHEFFY                PHONE NO : 972 4 6177000 
9 HALAMISH ST.                    SE DECISION MADE: 26-JUL-16
CAESAREA  IL 3088900              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal
COVIDIEN                          510(k) NO: K153074(Traditional)
ATTN: Karin  Desjardins           PHONE NO : 508 4521856 
15 HAMPSHIRE STREET               SE DECISION MADE: 06-JUL-16
MANSFILED MA  02048               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IvyAIR Meniscus System, Curved, IvyAIR Meniscus System, Straight, IvyAIR Meniscus System, Reverse Curved
Ivy Sports Medicine, LLC          510(k) NO: K153087(Traditional)
ATTN: John  Dichiara              PHONE NO : 650 5620800 
545 Penobscot Drive               SE DECISION MADE: 14-JUL-16
Redwood City CA  94063            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Belvedere™ Lateral Plating System
NEUROSTRUCTURES, INC.             510(k) NO: K153097(Traditional)
ATTN: Moti  Altarac               PHONE NO : 800 3526103 
16 TECHNOLOGY DR. SUITE 165       SE DECISION MADE: 15-JUL-16
IRVINE CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MLX™ - Medial Lateral Expandable Lumbar Interbody System
NuVasive, Incorporated            510(k) NO: K153105(Traditional)
ATTN: Olga  Lewis                 PHONE NO : 858 3205257 
7475 Lusk Blvd.                   SE DECISION MADE: 11-JUL-16
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM
AESKU. SYSTEMS GMBH & CO. KG      510(k) NO: K153117(Traditional)
ATTN: TOM  STECKLUM               PHONE NO : 49 6734 96220 
MIKROFORUM RING 3                 SE DECISION MADE: 28-JUL-16
WENDELSHEIM  DE 55234             510(k) STATEMENT
                                                    

DEVICE: DuraLazeTM HoLEP Laser Fiber
MedKey, LLC                       510(k) NO: K153124(Traditional)
ATTN: Jeff  Zerfas                PHONE NO : 812 3459946 
2620 N. Walnut Street, SUite 1205 SE DECISION MADE: 26-JUL-16
Bloomington IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls 
INSTRUMENTATION LABORATORY CO.    510(k) NO: K153137(Traditional)
ATTN: Carol  Marble               PHONE NO : 718 8614467 
180 HARTWELL Road                 SE DECISION MADE: 08-JUL-16
BEDFORD MA  01730                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lumipulse G TP-N Immunoreaction Cartridge Set
Fujirebio Diagnostics, Inc.       510(k) NO: K153145(Traditional)
ATTN: Diana  Dickson              PHONE NO : 610 2403917 
201 Great Valley Parkway          SE DECISION MADE: 05-JUL-16
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ShefaBone SCPC Resorbable Bone Graft
THE IMPLANTECH INC./SHEFABONE     510(k) NO: K153230(Traditional)
ATTN: AHMED  EL-GHANNAM           PHONE NO : 704 6877730 
9016 CLIFF CAMERON DR., #201      SE DECISION MADE: 14-JUL-16
CHARLOTTE NC  28269               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer
GC AMERICA, INC.                  510(k) NO: K153231(Traditional)
ATTN: Mark  Heiss                 PHONE NO : 708 5970900 
3737 W. 127TH ST.                 SE DECISION MADE: 06-JUL-16
ALSIP IL  60803                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AirLife Adult Heated Wire Circuit
CAREFUSION INC                    510(k) NO: K153234(Traditional)
ATTN: ERIKA  FERNANDEZ            PHONE NO : 847 3628097 
75 N FAIRWAY DRIVE                SE DECISION MADE: 07-JUL-16
VERNON HILLS IL  600601           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Styrker OrthoMap Express Knee System
STRYKER CORPORATE                 510(k) NO: K153240(Traditional)
ATTN: Becky  Ditty                PHONE NO : 269 3893434 
BOETZINGER STR. 41                SE DECISION MADE: 07-JUL-16
FREIBURG, BADEN-WUERTTEMBERG  DE 7510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash
ORIGIO A/S                        510(k) NO: K153267(Traditional)
ATTN: Tove   Kjaer                PHONE NO : 45 467 90220 
KNARDRUPVEJ 2                     SE DECISION MADE: 22-JUL-16
MALOV  DK 2760                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NR Line Implant System
DENTIUM CO., LTD.                 510(k) NO: K153268(Traditional)
ATTN: YOUNJUNG  YUK               PHONE NO : 82 250 18560 
29 TEHERAN-RO, 87-GZL GANGNAM-GU  SE DECISION MADE: 20-JUL-16
SEOUL  KP 06167                   510(k) STATEMENT
                                                    

DEVICE: INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set
RELIEVANT MEDSYSTEMS              510(k) NO: K153272(Traditional)
ATTN: ADAM  SAVAKUS               PHONE NO : 650 3681000 
2688 MIDDLEFIELD ROAD, SUITE A    SE DECISION MADE: 09-JUL-16
REDWOOD CITY CA  94063            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MEDINAUT Kyphoplasty System
IMEDICOM Co., Ltd.                510(k) NO: K153296(Traditional)
ATTN: Bonggu  Ha                  PHONE NO : 82 31 4791156 
#612, 172, LS-ro                  SE DECISION MADE: 29-JUL-16
Gunpo-si  KR 435-824              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Gradia Plus
GC America Inc.                   510(k) NO: K153325(Traditional)
ATTN: Mark  Heiss                 PHONE NO : 708 9263090 
3737 W. 127th Street              SE DECISION MADE: 12-JUL-16
Alsip IL  60803                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SUNCO Mechanical Wheelchair, model SKW-9003
DANYANG SUNCO MACHINERY CO., LTD  510(k) NO: K153328(Traditional)
ATTN: JEN  KE-MIN                 PHONE NO : 86 511 86733686 
TAOJING ROAD, OPTICS INDUSTRIAL PASE DECISION MADE: 20-JUL-16
DANYANG CITY  CN 212300           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: i-STAT Alinity System with i-STAT Sodium test
ABBOTT POINT OF CARE INC.         510(k) NO: K153357(Traditional)
ATTN: MELISSA  ROBINSON           PHONE NO : 609 4549371 
400 COLLEGE ROAD EAST             SE DECISION MADE: 08-JUL-16
PRINCETON NJ  08540               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Red2Green Reusable Sharps Container
TRIUMVIRATE ENVIRONMENTAL, INC.   510(k) NO: K153363(Traditional)
ATTN: STEVE  TODISCO              PHONE NO : 888 8349697 
200 INNER BELT ROAD               SE DECISION MADE: 26-JUL-16
Somerville MA  02143              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LightStim Professional LED Bed
LED Intellectual Properties LLC   510(k) NO: K153399(Traditional)
ATTN: Steve  Marchese             PHONE NO : 949 5024088 
16552 Von Karman Ave              SE DECISION MADE: 05-JUL-16
Irvine CA  92606                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Panpac Disposable Pessary Fitting Set
Panpac Medical Corporation        510(k) NO: K153422(Special)
ATTN: YEN-MING   PAN              PHONE NO : 886 2 86472242 
6F-1,2, NO. 202, SEC.3 TA-TONG ROASE DECISION MADE: 14-JUL-16
SHI-CHIH DISTRICT  TW 22103       510(k) STATEMENT
                                                    

DEVICE: PathLoc-C Posterior Cervical Fixation System
L&K BIOMED CO., LTD.              510(k) NO: K153439(Traditional)
ATTN: Yerim  An                   PHONE NO : 82 267 171985 
#201, 202 16-25, DONGBAEKJUNGANG-RSE DECISION MADE: 21-JUL-16
Giheung-gu, Yongin-si  KR 446-916 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Braemar Telemetry Patch System
Braemar Manufacturing, LLC        510(k) NO: K153473(Special)
ATTN: Kent  Sayler                PHONE NO : 619 2437500 
3890 Murphy Canyon Road, Suite 100SE DECISION MADE: 22-JUL-16
San Diego CA  92123               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dillard Airway Dilatation System
INTUIT MEDICAL PRODUCTS, LLC      510(k) NO: K153484(Traditional)
ATTN: JACK  GRIFFIS               PHONE NO : 404 5836889 
6018 EAGLES REST TRAIL            SE DECISION MADE: 27-JUL-16
SUGAR HILL GA  30518              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Clip Flow
VOCO GmbH                         510(k) NO: K153493(Traditional)
ATTN: M. Th. Plaumann             PHONE NO : 49 4721 7190 
Anton-Flettner-Str. 1-3           SE DECISION MADE: 29-JUL-16
Cuxhaven  DE 27472                510(k) STATEMENT
                                                    

DEVICE: Operio
TOUL MEDITECH AB                  510(k) NO: K153498(Traditional)
ATTN: Tomas  Hansson              PHONE NO : 46 21 135000 
TUNBYTORPSGATAN 31                SE DECISION MADE: 20-JUL-16
Västerås  SE 72137                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tearaway Introducer Sheath, MicroSlide Tearaway Introducer
GALT MEDICAL CORP.                510(k) NO: K153533(Traditional)
ATTN: DAVID  DERRICK              PHONE NO : 972 2715177 
2220 MERRITT DR.                  SE DECISION MADE: 05-JUL-16
GARLAND TX  75041                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat System
IQuum, Inc.                       510(k) NO: K153544(Dual Track)
ATTN: Lingjun  Chen               PHONE NO : 508 2293203 
700 Nickerson Road                SE DECISION MADE: 25-JUL-16
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ABPM 7100, Hypertension Management Software
I.E.M. GMBH                       510(k) NO: K153557(Traditional)
ATTN: Hella   Witt                PHONE NO : 49 2402 95000 
COCKERILLSTR. 69                  SE DECISION MADE: 19-JUL-16
Stolberg  DE 52222                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: InMode Plus System
InMode MD Ltd.                    510(k) NO: K153568(Traditional)
ATTN: Ahava   Stein               PHONE NO : 972 49096307 
Tabor Building, Shaar Yokneam, POBSE DECISION MADE: 12-JUL-16
Yoqneam  IL 20692                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Juliet® Ti
SPINEART                          510(k) NO: K153621(Traditional)
ATTN: FRANCK  PENNESI             PHONE NO : 41 22 5701246 
INTERNATIONAL CENTER COINTRIN 20 RSE DECISION MADE: 15-JUL-16
Geneva  CH 1215                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sorbact Foam Gentle Border, Sorbact Superabsorbent
ABIGO Medical AB                  510(k) NO: K153674(Traditional)
ATTN: Annica  Corbe               PHONE NO : 0046 317 484950 
Ekonomivagen 5                    SE DECISION MADE: 01-JUL-16
Askim  SE SE-43633                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments
AESCULAP IMPLANT SYSTEMS, LLC     510(k) NO: K153700(Traditional)
ATTN: Paul  Amudala               PHONE NO : 610 9849303 
3773 Corporate Parkway            SE DECISION MADE: 08-JUL-16
Center Valley PA  18034           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: INTRAcel Premium Fractional RF Micro Needle (FRM) System
JEISYS MEDICAL, INC.              510(k) NO: K153727(Traditional)
ATTN: HYOSEOK  LEE                PHONE NO : 82 226 036417 
307 Daeryung Techno Town 8th, GamaSE DECISION MADE: 21-JUL-16
SEOUL  KR 153-775                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Blue Nitrile Examination Glove
QUBE MEDICAL PRODUCT SDN BHD      510(k) NO: K153732(Traditional)
ATTN: TEO SIONG YAM               PHONE NO : 06 03 60345857 
NO. 9, JALAN KPK 1/1, KAWASAN PERISE DECISION MADE: 29-JUL-16
RAWANG  MY 48020                  510(k) STATEMENT
                                                    

DEVICE: PROW FUSION-V
NLT SPINE LTD                     510(k) NO: K153786(Traditional)
ATTN: Eti   Zinger                PHONE NO : 972 3 6344514 
6 YAD HARUTZIM ST.                SE DECISION MADE: 11-JUL-16
KFAR-SABA  IL 4464103             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Steth IO
STRATOSCIENTIFIC, INC.            510(k) NO: K160016(Traditional)
ATTN: SUMAN  MULUMUDI             PHONE NO : 425 8764310 
1574 NORTHWEST 190TH STREET       SE DECISION MADE: 15-JUL-16
SHORELINE WA  98177               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Quickie Pulse (Models 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC) and Zippie ZM-310 (Models BC, SC)
SUNRISE MEDICAL (US) LLC          510(k) NO: K160031(Traditional)
ATTN: LAURIE H ROBERTS            PHONE NO : 559 3482572 
2842 BUSINESS PARK AV             SE DECISION MADE: 14-JUL-16
FRESNO CA  93727                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UniStrip1 Generic Blood Glucose Test Strips
OK BIOTECH CO., LTD.              510(k) NO: K160038(Traditional)
ATTN: KE-MIN  JEN                 PHONE NO : 886 3 5160258 
NO. 91, SEC. 2, GONGDAO 5TH ROAD  SE DECISION MADE: 29-JUL-16
HSINCHU CITY  TW 30070            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: t:slim Insulin Delivery System
Tandem Diabetes Care, Inc.        510(k) NO: K160056(Traditional)
ATTN: Michael  Sarrasin           PHONE NO : 858 3666900 
11045 Roselle Street              SE DECISION MADE: 25-JUL-16
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set
JBW7 Innovations, LLC             510(k) NO: K160077(Traditional)
ATTN: Jason B Wynberg             PHONE NO : 248 996 2775
22200 W. 11 Mile Road, # 4182     SE DECISION MADE: 12-JUL-16
Southfield MI  48037              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Puritan Opti-Tranz Cary-Blair Collection and Transport System
PURITAN MEDICAL PRODUCTS LLC      510(k) NO: K160082(Traditional)
ATTN: MEHDI  KARAMCHI             PHONE NO : 207 8763311 3284
31 SCHOOL STREET P.O. BOX 149     SE DECISION MADE: 29-JUL-16
GUILFORD ME  04443-0149           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SHOFU Enamel Conditioner
SHOFU DENTAL CORPORATION          510(k) NO: K160086(Traditional)
ATTN: MAURO  MALZYNER             PHONE NO : 760 7363277 
1225 STONE DRIVE                  SE DECISION MADE: 21-JUL-16
SAN MARCOS CA  92078              510(k) STATEMENT
                                                    

DEVICE: Cydar EV
Cydar Ltd.                        510(k) NO: K160088(Traditional)
ATTN: John  Clarke                PHONE NO : 44 1223 778020 
Bulbeck Mill, Mill Lane           SE DECISION MADE: 07-JUL-16
Barrington  GB CB22 7QY           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SinuBand
BIOINSPIRE TECHNOLOGIES, INCORPORA510(k) NO: K160101(Traditional)
ATTN: DORNA  HAKIMIMEHR           PHONE NO : 707 2395707 
2450 EMBARCADERO WAY              SE DECISION MADE: 27-JUL-16
PALO ALTO CA  94303-3313          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Amber Mill Series and Amber Press Series
HASS CORP.                        510(k) NO: K160102(Traditional)
ATTN: YONGSU  KIM                 PHONE NO : 82 70 77121300 
77-14, GWAHAKDANJI-RO             SE DECISION MADE: 14-JUL-16
GANGNEUNG-SI  KR 210-340          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DiamondTOUCH Inflation Device and Fluid Dispensing Syringe
Merit Medical Systems, Inc.       510(k) NO: K160107(Traditional)
ATTN: Dan W Lindsay               PHONE NO : 801 2084408 
1600 West Merit Parkway           SE DECISION MADE: 29-JUL-16
South Jordan UT  84095            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Apinator
Allen J. Moses, DDS LTD           510(k) NO: K160123(Abbreviated)
ATTN: Allen J Moses               PHONE NO : 312 9930430 
233 S. Wacker Drive               SE DECISION MADE: 12-JUL-16
Chicago IL  60606                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: rainbow LS Block
GENOSS CO., LTD.                  510(k) NO: K160144(Traditional)
ATTN: HAN  YEIN                   PHONE NO : 82 31 8885100 
1F GYEONGGI R&DB CENTER, 105 GWANGSE DECISION MADE: 21-JUL-16
SUWON-SI  KR 16229                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NobelProcera HT ML FCZ Implant Bridge and Framework
Nobel Biocare AB                  510(k) NO: K160158(Traditional)
ATTN: Charlemagne  Chua           PHONE NO : 714 2824800 7830
BOX 5190, SE-402 26, Vastra HamngaSE DECISION MADE: 25-JUL-16
Goteborg  SE SE-411 17            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Atteris Antimicrobial Skin & Wound Cleanser
ROCHAL INDUSTRIES LLC             510(k) NO: K160192(Traditional)
ATTN: WILLIAM J.  COULSTON        PHONE NO : 210 8706534 
12719 CRANES MILL                 SE DECISION MADE: 28-JUL-16
SAN ANTONIO TX  78230             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Polux , Minerva and Atropos PTA Balloon Dilatation Catheter
Brosmed Medical Co., Ltd.         510(k) NO: K160256(Traditional)
ATTN: Tina   Yin                  PHONE NO : 86 769 22892018 
15th Bldg., SMEs Venture Park, SonSE DECISION MADE: 29-JUL-16
Dongguan  CN 523808               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12
SAN-M PACKAGE CO., LTD.           510(k) NO: K160271(Abbreviated)
ATTN: Shogo  Nagao                PHONE NO : 81 547 454125 
1086-1 OJIRO                      SE DECISION MADE: 15-JUL-16
SHIMADA-CITY  JP 428-8652         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT)
Fudakang Industrial Co., Ltd      510(k) NO: K160308(Special)
ATTN: Bob  Yu                     PHONE NO : 86 769 81098181 
No. 8 Yinghe Road, Yuanjiangyuan MSE DECISION MADE: 15-JUL-16
Dongguan  CN 523560               510(k) STATEMENT
                                                    

DEVICE: Medline ReNewal Reprocessed LigaSure Blunt Tip Open Sealer/Divider
SURGICAL INSTRUMENT SERVICE AND SA510(k) NO: K160333(Traditional)
ATTN: BRANDI J. PANTELEON         PHONE NO : 541 9233310 
2747 SW 6TH ST.                   SE DECISION MADE: 20-JUL-16
REDMOND OR  97756                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cardinal Health Isolation Gown
Cardinal Health 200, LLC          510(k) NO: K160339(Traditional)
ATTN: Caroline  Miceli            PHONE NO : 847 8876864 
1500 Waukegan Road                SE DECISION MADE: 28-JUL-16
Waukegan IL  60085                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
Nissin-Metec China Co., Ltd.      510(k) NO: K160367(Traditional)
ATTN: Xiwei  Shen                 PHONE NO : 86 512 36857051 
No. 883 Beimen Road, Yushan Town  SE DECISION MADE: 27-JUL-16
Kunshan  CN 215316                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: URITEK TC-201 URINE CHEMISTRY TEST SYSTEM
TECO DIAGNOSTICS, INC.            510(k) NO: K160372(Traditional)
ATTN: AQUIL  MERCHANT             PHONE NO : 714 4631111 
1268 N. LAKEVIEW AVE.             SE DECISION MADE: 22-JUL-16
ANAHEIM CA  92807                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Precision Screw
CRYPTYCH PTY LTD                  510(k) NO: K160385(Traditional)
ATTN: GREG  ROGER                 PHONE NO : 61 414 899799 
SUITE 106, 275 ALFRED STREET      SE DECISION MADE: 27-JUL-16
North Sydney  AU 2060             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Skyn Original Polyisoprene Lubricated Male Condom
Ansell Healthcare Products, LLC   510(k) NO: K160399(Abbreviated)
ATTN: Robert  Mahler              PHONE NO : 732 3452174 
111 Wood Avenue South, Suite 210  SE DECISION MADE: 25-JUL-16
Iselin NJ  08830                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cardinal Health Vinyl Powder-Free Exam Gloves with Neu-thera Coating
CARDINAL HEALTH, INC.             510(k) NO: K160411(Traditional)
ATTN: Megan  Middaugh             PHONE NO : 847 8876812 
1500 WAUKEGAN ROAD                SE DECISION MADE: 25-JUL-16
WAUKEGAN IL  60085                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CAD/CAMouflage Milling Bock
Prismatik Dentalcraft, Inc.       510(k) NO: K160425(Traditional)
ATTN: ARMIN  ZEHTABCHI            PHONE NO : 949 2251234 
2212 Dupont Drive, Suite P        SE DECISION MADE: 15-JUL-16
Irvine CA  92612                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ActiveCare Home
MEDICAL COMPRESSION SYSTEMS (DBN) 510(k) NO: K160431(Traditional)
ATTN: YAKI  BARAK                 PHONE NO : 972 4 6266630 
12 HA'ILAN STREET, PO BOX 75      SE DECISION MADE: 13-JUL-16
OR AKIVA  IL 30600                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: V-PRO® 1 Plus and V-PRO® maX Low Temperature
STERIS CORPORATION                510(k) NO: K160433(Traditional)
ATTN: BILL  BRODBECK              PHONE NO : 440 3927690 
5960 HEISLEY ROAD                 SE DECISION MADE: 06-JUL-16
MENTOR OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SunTech CT40 Spot-check Vital Signs Device
SUNTECH MEDICAL                   510(k) NO: K160439(Abbreviated)
ATTN: CHUCK  SETZER               PHONE NO : 919 6542334 
507 AIRPORT BLVD SUITE 117        SE DECISION MADE: 06-JUL-16
MORRISVILLE NC  27560             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ARTLINE
HEALTH LINE INTERNATIONAL CORPORAT510(k) NO: K160448(Traditional)
ATTN: JOEL  FAULKNER              PHONE NO : 801 7737798 
5675 WEST 300 SOUTH               SE DECISION MADE: 12-JUL-16
SALT LAKE CITY UT  84101          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Spinal Elements' Spinous Process Plate System
Spinal Elements Inc.              510(k) NO: K160465(Traditional)
ATTN: Julie  Lamothe              PHONE NO : 760 6071816 
3115 Melrose Dr., Suite 200       SE DECISION MADE: 28-JUL-16
Carlsbad CA  92010                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SculpSure
CYNOSURE, INC.                    510(k) NO: K160470(Traditional)
ATTN: Aastha  Kohli               PHONE NO : 781 9932394 
5 CARLISLE ROAD                   SE DECISION MADE: 21-JUL-16
WESTFORD MA  01886                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: The Luco Hybrid OSA Appliance
LUCO HYBRID OSA APPLIANCE INC.    510(k) NO: K160477(Traditional)
ATTN: Ken  Luco                   PHONE NO : 1 613 5446019 
1419 BUTTERNUT CREEK ROAD         SE DECISION MADE: 29-JUL-16
KINGSTON  CA K7L 4V3              510(k) STATEMENT
                                                    

DEVICE: t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater
Tandem Diabetes Care, Inc.        510(k) NO: K160482(Traditional)
ATTN: Michael  Sarrasin           PHONE NO : 858 3666900 
11045 Roselle Street              SE DECISION MADE: 13-JUL-16
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RI Witness Embryology Heated Plate
RESEARCH INSTRUMENTS LIMITED      510(k) NO: K160504(Traditional)
ATTN: Wendy   Hassan              PHONE NO : 44 1326 372753 
BICKLAND INDUSTRIAL PARK          SE DECISION MADE: 18-JUL-16
FALMOUTH  GB TR11 4TA             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LEONI ORION System
LEONI CIA CABLE SYSTEM            510(k) NO: K160518(Traditional)
ATTN: AURELIE   GENHO             PHONE NO : 33 0237 912182 
5 AVE VICTOR HUGO                 SE DECISION MADE: 14-JUL-16
CHARTRES  FR 28000                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VALO Grand
ULTRADENT PRODUCTS, INC.          510(k) NO: K160551(Special)
ATTN: Marie   Hess                PHONE NO : 801 5534610 
505 WEST 10200 SOUTH              SE DECISION MADE: 13-JUL-16
SOUTH JORDAN UT  84095            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Full Automatic (NIBP) Blood Pressure Monitor
HEALTH & LIFE CO.,LTD.            510(k) NO: K160557(Traditional)
ATTN: SARAH  SU                   PHONE NO : 886 2 82271300 1201
9F, NO.186, JIAN YI RD            SE DECISION MADE: 06-JUL-16
ZHONGHE DISTRICT, NEW TAIPEI CITY 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NeuGuide
POP Medical Solutions             510(k) NO: K160569(Traditional)
ATTN: Guy  Ohad                   PHONE NO : 972 3 7684948 
27 Habarzel ST.                   SE DECISION MADE: 06-JUL-16
Tel Aviv  IL 6971039              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PacEndo Chlorhexidine
PAC-DENT INTERNATIONAL, INC.      510(k) NO: K160577(Traditional)
ATTN: Wenying  Zhu                PHONE NO : 909 8390888 
670 ENDEAVOR CIRCLE               SE DECISION MADE: 25-JUL-16
BREA CA  92821                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BEAUTIFIL II LS
SHOFU DENTAL CORPORATION          510(k) NO: K160596(Traditional)
ATTN: Mauro  Malzyner             PHONE NO : 760 7363277 
1225 STONE DRIVE                  SE DECISION MADE: 27-JUL-16
SAN MARCOS CA  92078              510(k) STATEMENT
                                                    

DEVICE: Cure™ Anterior Cervical Plate (ACP) System
MEDITECH SPINE, LLC               510(k) NO: K160604(Traditional)
ATTN: BRUCE  DUNAWAY              PHONE NO : 678 9745287 
1447 PEACHTREE ST NE SUITE 440    SE DECISION MADE: 01-JUL-16
ATLANTA GA  30309                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MectaLIF Anterior Stand-Alone
MEDACTA INTERNATIONAL             510(k) NO: K160605(Traditional)
ATTN: MICHAEL G. LOITERMAN        PHONE NO : 41 91 6966060 
STRADA REGINA                     SE DECISION MADE: 21-JUL-16
CASTEL SAN PIETRO  CH CH 6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PicoWay Laser System
SYNERON CANDELA CORPORATION       510(k) NO: K160607(Traditional)
ATTN: Ruthie   Amir               PHONE NO : 508 3587400 330
530 BOSTON POST ROAD              SE DECISION MADE: 05-JUL-16
Wayland MA  01778                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Soberlink Cellular Device and Sober Sky Web Portal
SOBERLINK HEALTHCARE LLC          510(k) NO: K160613(Traditional)
ATTN: JENNA  COSTA                PHONE NO : 714 9757200 
16787 BEACH BLVD #211             SE DECISION MADE: 14-JUL-16
HUNTINGTON BEACH CA  92647        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: InPen
COMPANION MEDICAL, INC.           510(k) NO: K160629(Traditional)
ATTN: JASPER  BENKE               PHONE NO : 858 5220252 
16486 BERNARDO CENTER, DRIVE SUITESE DECISION MADE: 26-JUL-16
SAN DIEGO CA  92128               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Keos Lumbar IBFD
KEOS                              510(k) NO: K160631(Traditional)
ATTN: MARK F. SCHENK              PHONE NO : 610 5078255 
1824 COLONIAL VILLAGE LANE        SE DECISION MADE: 15-JUL-16
LANCASTER PA  17601               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Atteris No-Sting Skin Protectant
ROCHAL INDUSTRIES LLC             510(k) NO: K160684(Traditional)
ATTN: WILLIAM  J. COULSTON        PHONE NO : 210 8706534 
12719 CRANES MILL                 SE DECISION MADE: 26-JUL-16
SAN ANTONIO TX  78230             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: myPatch-s
DMS-SERVICE LLC                   510(k) NO: K160704(Traditional)
ATTN: LYNDA  COLE                 PHONE NO : 855 4072824 
11845 W. OLYMPIC BLVD STE 880W    SE DECISION MADE: 15-JUL-16
LOS ANGELES CA  90064             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AccuLIF TL and PL Cage
STRYKER CORPORATION               510(k) NO: K160715(Traditional)
ATTN: AAKASH  JAIN                PHONE NO : 201 7498074 
2 PEARL COURT                     SE DECISION MADE: 08-JUL-16
ALLENDALE NJ  07401               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CorticaLINK Spinal Fusion Platform
FACETLINK DBA LINKSPINE           510(k) NO: K160722(Traditional)
ATTN: MASSIMO  CALAFIORE          PHONE NO : 973 6274171 
101 ROUNDHILL DRIVE               SE DECISION MADE: 07-JUL-16
ROCKAWAY NJ  07866                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LOOK PTFE Suture
Surgical Specialties Corporation  510(k) NO: K160744(Traditional)
ATTN: Karen  Sanchez              PHONE NO : 484 5574996 
Corredor Tijuana-Rosarito 2000, #2SE DECISION MADE: 13-JUL-16
Tijuana  MX 22235                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Angel Catheter
BIO2 MEDICAL, INC.                510(k) NO: K160747(Traditional)
ATTN: CHRISTOPHER E. BANAS        PHONE NO : 720 8335660 
4670 TABLE MOUNTAIN DRIVE         SE DECISION MADE: 28-JUL-16
GOLDEN CO  80403                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reliance Solo Sterilization Wrap, Reliance Tandem Sterilization Wrap
AHLSTROM NONWOVENS LLC            510(k) NO: K160755(Traditional)
ATTN: GARY  JACKSON               PHONE NO : 860 6548556 
2 ELM STREET                      SE DECISION MADE: 27-JUL-16
WINDSOR LOCKS CT  06096           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM)
AXIS-SHIELD DIAGNOSTICS LIMITED   510(k) NO: K160757(Traditional)
ATTN: CLAIRE I. DORA              PHONE NO : 44 013 82422000 232
THE TECHNOLOGY PARK LUNA PLACE    SE DECISION MADE: 26-JUL-16
DUNDEE  GB DD2 1XA                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PeriCoach OTC
ANALYTICA LTD.                    510(k) NO: K160758(Traditional)
ATTN: GEOFF  DALY                 PHONE NO : 61 7 32781950 
320 ADELAIDE STREET               SE DECISION MADE: 11-JUL-16
BRISBANE  AU 4000                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens
CooperVision, Inc.                510(k) NO: K160803(Traditional)
ATTN: Roya  Borazjani             PHONE NO : 925 6213723 
6150 Stoneridge Mall Rd., Suite 37SE DECISION MADE: 13-JUL-16
Pleasanton CA  94588              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: INTRAFIX(TM) Advance Tibial Fastener System
MEDOS INTERNATIONAL SARL          510(k) NO: K160804(Traditional)
ATTN: KRISTINE  CHRISTO           PHONE NO : 508 8283359 
CHEMIN-BLANC 38, CASE POSTALE     SE DECISION MADE: 19-JUL-16
LE LOCLE  CH CH 2400              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EasyStep
STRYKER GMBH                      510(k) NO: K160813(Traditional)
ATTN: Garry  T.  Hayeck           PHONE NO : 201 8316802 
325 CORPORATE DRIVE               SE DECISION MADE: 26-JUL-16
MAHWAH NJ  07430                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Integra External Fixation System
Ascension Orthopedics             510(k) NO: K160830(Special)
ATTN: Jayana  Kenana              PHONE NO : 609 9362657 
8700 Cameron Road, Suite 100      SE DECISION MADE: 06-JUL-16
Austin TX  78754                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AmplifEYE
MEDIVATORS, INC.                  510(k) NO: K160846(Traditional)
ATTN: Jeff  Kasoff                PHONE NO : 936 5214213 
3150 POLLOK DR.                   SE DECISION MADE: 14-JUL-16
CONROE TX  77303                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Wingman 18 Crossing Catheter
ReFlow Medical, Inc.              510(k) NO: K160848(Traditional)
ATTN: Rebecca K Pine              PHONE NO : 760 8095178 
1003 Calle Sombra                 SE DECISION MADE: 14-JUL-16
San Clemente CA  92673            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E)
CONTAMAC LTD.                     510(k) NO: K160859(Traditional)
ATTN: ROB  MCGREGOR               PHONE NO : 44 179 9542000 
CARLTON HOUSE SHIRE HILL          SE DECISION MADE: 13-JUL-16
SAFFRON WALDEN  GB cb11 3au       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PBS(-), Phosphate Buffered Saline
KITAZATO BIOPHARMA CO., LTD.      510(k) NO: K160863(Traditional)
ATTN: FUTOSHI  INOUE              PHONE NO : 81 545 662202 
81 NAKIJIMA                       SE DECISION MADE: 28-JUL-16
FUJI  JP 416-0907                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating  
CARDINAL HEALTH, INC.             510(k) NO: K160875(Traditional)
ATTN: Megan   Middaugh            PHONE NO : 847 8876812 
1500 WAUKEGAN RD                  SE DECISION MADE: 11-JUL-16
WAUKEGAN IL  60085                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cook Intraosseous Infusion Needles
COOK INCORPORATED                 510(k) NO: K160887(Special)
ATTN: JULIA  FERGUSON             PHONE NO : 812 3353575 104554
750 DANIELS WAY                   SE DECISION MADE: 26-JUL-16
BLOOMINGTON IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HANAROCare ReJu
M.I.TECH CO.,LTD                  510(k) NO: K160893(Traditional)
ATTN: HWANG  MI-SUNG              PHONE NO : 82 31 6625645 
174, HABUK 2-GIL, JINWI-MYEON     SE DECISION MADE: 27-JUL-16
Pyeongtaek-si  KR 17706           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ULTRASHAPE POWER SYSTEM
SYNERON MEDICAL LTD               510(k) NO: K160896(Traditional)
ATTN: Ruthie   Amir               PHONE NO : 972 73 2442200 
TAVOR BUILDING, INDUSTRIAL ZONE, PSE DECISION MADE: 08-JUL-16
Yokneam Illit  IL 20692           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Expedium Spine System, VIPER and VIPER 2 Systems
MEDOS INTERNATIONAL SARL          510(k) NO: K160904(Traditional)
ATTN: Karen   Sylvia              PHONE NO : 508 9773804 
CHEMIN-BLANC 38                   SE DECISION MADE: 01-JUL-16
LE LOCLE  CH 2400                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rampart O Lumbar Interbody Fusion Device, Rampart T Lumbar Interbody Fusion Device, Rampart A lumbar Interbody Fusion Device
SPINEOLOGY INC.                   510(k) NO: K160906(Traditional)
ATTN: JACQUELINE A HAUGE          PHONE NO : 651 2568500 
7800 3RD STREET, SUITE 600        SE DECISION MADE: 14-JUL-16
ST. PAUL MN  55128                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DePuy Actis DuoFix Hip Prosthesis
DEPUY (IRELAND)                   510(k) NO: K160907(Traditional)
ATTN: Jaime   Weeks               PHONE NO : 574 3727591 
LOUGHBEG RINGASKIDDY              SE DECISION MADE: 19-JUL-16
Co. Cork  IE                      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vis-U-All Low Temperature Sterilization Pouch/Tubing
STERIS CORPORATION                510(k) NO: K160908(Traditional)
ATTN: ANTHONY  PIOTRKOWSKI        PHONE NO : 440 3927437 
5960 HEISLEY RD                   SE DECISION MADE: 22-JUL-16
MENTOR OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Elecsys Syphilis
ROCHE DIAGNOSTICS                 510(k) NO: K160910(Traditional)
ATTN: ANGELO  PEREIRA             PHONE NO : 317 5213544 
9115 HAGUE RD                     SE DECISION MADE: 28-JUL-16
INDIANAPOLIS IN  46250            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 8ch Foot Ankle Coil
Shenzhen RF Tech Co., Ltd.        510(k) NO: K160935(Traditional)
ATTN: Ke  Xi                      PHONE NO : 086 755 26641989 
2-F, Bld4, Juhui Industrial Park, SE DECISION MADE: 28-JUL-16
Shenzhen  CN 518132               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX CPS 4 IR Lamp System LUMIX CPS 5 IR Lamp System
USA LASER BIOTECH INC.            510(k) NO: K160947(Traditional)
ATTN: NELSON  MARQUINA            PHONE NO : 804 3772234 
9210 FOREST HILL AVENUE SUITE B-3 SE DECISION MADE: 05-JUL-16
RICHMOND VA  23235                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tritanium® PL Cage
STRYKER                           510(k) NO: K160955(Traditional)
ATTN: Deirdre  Jayko              PHONE NO : 201 7488339 
2 Pearl Court                     SE DECISION MADE: 21-JUL-16
Allendale NJ  07401               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LD-Oxi system
LD TECHNOLOGY LLC                 510(k) NO: K160956(Special)
ATTN: Albert  MAAREK              PHONE NO : 305 3799900 
100N. Biscayne Blvd, suite 500    SE DECISION MADE: 06-JUL-16
Miami FL  33132                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mozec NC-Rx PTCA Baloon Dilatation Catheter
MERIL LIFE SCIENCES PRIVATE LIMITE510(k) NO: K160961(Traditional)
ATTN: Utpal  Thakor               PHONE NO : 91 960 1260306 
Bilakhia House, Survey No. 135/139SE DECISION MADE: 30-JUL-16
Vapi  IN 396191                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PolyDev Soft Contact Lenses
Polydev Ltd.                      510(k) NO: K160977(Traditional)
ATTN: John  Mulvihill             PHONE NO : 353 876 873128 
Tinure Rd                         SE DECISION MADE: 13-JUL-16
Collon  IE                        510(k) STATEMENT
                                                    

DEVICE: LITe BIO Delivery System
STRYKER CORPORATION               510(k) NO: K160978(Traditional)
ATTN: Meriam  Gabera              PHONE NO : 201 7608043 
2 PEARL COURT                     SE DECISION MADE: 08-JUL-16
ALLENDALE NJ  07401               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MultiScan G-Arm System
BEIJING EAST WHALE IMAGING TECHNOL510(k) NO: K160984(Traditional)
ATTN: SHARON  FAN                 PHONE NO : 86 10 67892355 8866
B2-2 NEW CITY INDUSTRIAL PARK, NO.SE DECISION MADE: 20-JUL-16
BEIJING  CN 100023                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ReWalk(TM)
REWALK ROBOTICS INC.              510(k) NO: K160987(Special)
ATTN: JOHN  HAMILTON              PHONE NO : 508 2511154 
33 LOCKE DRIVE                    SE DECISION MADE: 22-JUL-16
MARLBOROUGH MA  01752             510(k) STATEMENT
                                                    

DEVICE: Biopor, AOC Porous Polyethylene, Cerepor
CEREMED, INC.                     510(k) NO: K160988(Traditional)
ATTN: CHELSEA  MITCHELL           PHONE NO : 310 8152125 
3643 LENAWEE AVE.                 SE DECISION MADE: 14-JUL-16
LOS ANGELES CA  90016             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mm
Dunamis LLC                       510(k) NO: K160996(Traditional)
ATTN: Prithvi Raj Chavan          PHONE NO : 731 2172533 
693 Sherling Lake Rd Apt 122      SE DECISION MADE: 06-JUL-16
Greenville AL  36037              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GC85A
SAMSUNG ELECTRONICS CO., LTD.     510(k) NO: K160997(Traditional)
ATTN: CHULSIN  KIM                PHONE NO : 82 312 007661 
129, SAMSUNG-RO YEONGTONG-GU      SE DECISION MADE: 06-JUL-16
SUWON-SI,   KR 443-742            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE POWDER FREE SURGICAL GLOVE
HARTALEGA SDN. BHD.               510(k) NO: K161008(Traditional)
ATTN: KUAN KAM HON                PHONE NO : 603 62801733 
DATARAN SD PJU 9                  SE DECISION MADE: 28-JUL-16
BANDAR SRI DAMANSARA  MY 52200    510(k) STATEMENT
                                                    

DEVICE: Aquilion ONE Vision with FIRST 2.0 (CCRS-001B) V7.4
TOSHIBA MEDICAL SYSTEMS CORPORATIO510(k) NO: K161009(Traditional)
ATTN: PAUL  BIGGINS               PHONE NO : 714 6697808 
1385 SHIMOISHIGAMI                SE DECISION MADE: 22-JUL-16
OTAWARA-SHI  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Easy-Load Lens Delivery System
Bausch and Lomb, Inc.             510(k) NO: K161012(Special)
ATTN: Joyce  Zhong                PHONE NO : 949 3985764 
50 Technology Drive               SE DECISION MADE: 06-JUL-16
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: XSTAT-12, 3-Pack, XSTAT-12, 1-Pack
REVMEDX, INC.                     510(k) NO: K161020(Traditional)
ATTN: AMY K. POINTER              PHONE NO : 503 2182172 
25999 SW CANYON CREEK ROAD SUITE CSE DECISION MADE: 28-JUL-16
WILSONVILLE OR  97070             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: K2M Growing Spine System
K2M, Inc.                         510(k) NO: K161028(Traditional)
ATTN: Nancy  Giezen               PHONE NO : 571 9192000 
751 Miller Drive SE               SE DECISION MADE: 22-JUL-16
Leesburg VA  20175                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AssureTech Methamphetamine  Tests (Strip, Panel Dip, Quick Cup, Turn-Key  Split Cup), AssureTech Phencyclidine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Marijuana  Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) 
ASSURE TECH (HANGZHOU) CO., LTD.  510(k) NO: K161044(Traditional)
ATTN: SHISHENG  LING              PHONE NO : 86 571 88868960 
NO. 10, XIYUANSAN RD., WESTLAKE ECSE DECISION MADE: 06-JUL-16
HANGZHOU  CN 310030               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Conventus Orthopaedics Ulna Fixation System
CONVENTUS ORTHOPAEDICS, INC.      510(k) NO: K161048(Traditional)
ATTN: KENT  LIND                  PHONE NO : 763 5155003 
10200 73RD AVENUE NORTH, SUITE 122SE DECISION MADE: 26-JUL-16
MAPLE GROVE MN  55369             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OsteoFab Patient Specific Facial Device
OXFORD PERFORMANCE MATERIALS, INC.510(k) NO: K161052(Special)
ATTN: Leigh   Ayres               PHONE NO : 860 6989300 
30 S Satellite Road               SE DECISION MADE: 20-JUL-16
South Windsor CT  06074           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji – 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15
Fuji Dynamics Ltd                 510(k) NO: K161055(Traditional)
ATTN: Kam Tim Ng                  PHONE NO : 852 27864218 
1-3, 23/F., Laws Commercial Plaza,SE DECISION MADE: 12-JUL-16
Hong Kong  CN                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cannulated Screw
MIAMI DEVICE SOLUTIONS, LLC       510(k) NO: K161058(Traditional)
ATTN: MARKKU  BIEDERMANN          PHONE NO : 786 4221400 
7620 NW 25TH STREET UNIT 3        SE DECISION MADE: 29-JUL-16
MIAMI FL  33122                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Grey Vinyl Examination Gloves
ZIBO FLOURISH TRADING CO., LTD.   510(k) NO: K161072(Traditional)
ATTN: KOU  LINGLING               PHONE NO : 86 0533 3819144 
NAQI ROAD, ZHANGDIAN DISTRICT     SE DECISION MADE: 14-JUL-16
ZIBO  CN 255000                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: sensiLight Mini
EL GLOBAL TRADE LTD               510(k) NO: K161089(Traditional)
ATTN: YAEL  LIEBES-PEER           PHONE NO : 972 978 89067 
8 TZORAN ST, P.O. BOX 8242        SE DECISION MADE: 08-JUL-16
NETANYA  IL 4250604               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SIMPLANT Online Case Review and SIMPLANT Editor
DENTSPLY SIRONA                   510(k) NO: K161118(Traditional)
ATTN: HELEN  LEWIS                PHONE NO : 717 4871332 
221 WEST PHILADELPHIA STREET SUITESE DECISION MADE: 28-JUL-16
York PA  17404                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dextera MicroCutter 5/80 Blue Reload, Dextera MicroCutter 5/80 Blue Curved Tip Reload
CARDICA, INC.                     510(k) NO: K161137(Traditional)
ATTN: Greg   Watson               PHONE NO : 949 4129808 
900 Saginaw Dr                    SE DECISION MADE: 20-JUL-16
Redwood City CA  94063            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: St. Louis Band
ORTHOMERICA PRODUCTS, INC.        510(k) NO: K161138(Traditional)
ATTN: DAVID  C. KERR              PHONE NO : 407 2906592 
6333 NORTH ORANGE BLOSSOM TRAIL   SE DECISION MADE: 20-JUL-16
ORLANDO FL  32810                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LIAISON H. pylori IgG, LIAISON H. pylori IgG Control Set 
DIASORIN, INC.                    510(k) NO: K161139(Traditional)
ATTN: JOHN  WALTER                PHONE NO : 651 4399710 
1951 NORTHWESTERN AVE.            SE DECISION MADE: 22-JUL-16
STILLWATER MN  55082-0285         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PASS OCT Spinal System
MEDICREA INTERNATIONAL S.A        510(k) NO: K161149(Traditional)
ATTN: David  Ryan                 PHONE NO : 33 472 018787 
14 PORTE DU GRAND LYON            SE DECISION MADE: 11-JUL-16
NEYRON  FR 01700                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Smartpatch PNS MicroLead and Accessories, Smartpatch PNS Stimulator, Pads, and Accessories, Smartpatch PNS MicroLead and Introducer, Smartpatch PNS Pads, 4 Packs                         
SPR THERAPEUTICS, LLC             510(k) NO: K161154(Traditional)
ATTN: Kathryn   Stager            PHONE NO : 216 3789108 
22901 MILLCREEK BLVD., SUITE 110  SE DECISION MADE: 23-JUL-16
CLEVELAND OH  44122               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Origin Coxa Vara Hip Stem
SIGNATURE ORTHOPAEDICS PTY LTD.   510(k) NO: K161155(Traditional)
ATTN: Declan  Brazil              PHONE NO : 61 294 285181 
7 SIRIUS ROAD                     SE DECISION MADE: 19-JUL-16
LANE COVE  AU 2066                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PROBEAT-V Proton Beam Therapy System with X-ray Limiting Accessory
HITACHI, LTD.                     510(k) NO: K161163(Traditional)
ATTN: Naoya  Nishimura            PHONE NO : 81 362 843741 
2-16-1 HIGACHI-UENO TAITO-KU      SE DECISION MADE: 13-JUL-16
Tokyo  JP 10-0015                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Liofilchem MIC Test Strip (MTS)- Ceftolozane/Tazobactam 0.016/4 - 256/4 mcg/mL
LIOFILCHEM S.R.L.                 510(k) NO: K161175(Traditional)
ATTN: FABIO  BRACCO               PHONE NO : 39 085 8930745 
64026 ROSETO DEGHLI               SE DECISION MADE: 12-JUL-16
ABRUZZI  IT                       510(k) STATEMENT
                                                    

DEVICE: Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® System
ZIMMER GMBH                       510(k) NO: K161192(Special)
ATTN: ROBERTO  TOMMASINI          PHONE NO : 41 58 8548264 
SULZERALLEE 8                     SE DECISION MADE: 08-JUL-16
WINTERTHUR  CH 8404               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3
USA LASER BIOTECH INC.            510(k) NO: K161198(Traditional)
ATTN: NELSON  MARQUINA            PHONE NO : 804 3772234 
9210 FOREST HILL AVENUE SUITE B-3 SE DECISION MADE: 26-JUL-16
RICHMOND VA  23235                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Gianturco-Roehm Bird’s Nest Vena Cava Filter
COOK INCORPORATED                 510(k) NO: K161218(Traditional)
ATTN: Jessica   Swafford          PHONE NO : 812 3353575 104260
750 DANIELS WAY                   SE DECISION MADE: 22-JUL-16
BLOOMINGTON IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TransContinental® M Spacers and InterContinental® Plate-Spacers
GLOBUS MEDICAL INC.               510(k) NO: K161223(Traditional)
ATTN: KELLY J. BAKER              PHONE NO : 610 9301800 1670
2560 GENERAL ARMISTEAD AVE.       SE DECISION MADE: 15-JUL-16
AUDUBON PA  19403                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL)
BIOMERIEUX, INC                   510(k) NO: K161227(Traditional)
ATTN: CHERECE L. JONES            PHONE NO : 314 7318684 
595 ANGLUM RD.                    SE DECISION MADE: 20-JUL-16
HAZELWOOD MO  63042               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: S-scan
Esaote S.p.A.                     510(k) NO: K161238(Special)
ATTN: Donatella  Ragghianti       PHONE NO : 011 39 0106547259 
Via Siffredi 58                   SE DECISION MADE: 08-JUL-16
Genovo  IT 16153                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TheraCem
BISCO, INC.                       510(k) NO: K161256(Traditional)
ATTN: Ryan   Hobson               PHONE NO : 847 5346143 
1100 WEST IRVING PARK ROAD        SE DECISION MADE: 29-JUL-16
SCHAUMBURG IL  60193              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NuVasive® VersaTie System
NUVASIVE, INCORPORATED            510(k) NO: K161265(Traditional)
ATTN: CYNTHIA  ADAMS              PHONE NO : 858 3204549 
7475 LUSK BLVD.                   SE DECISION MADE: 15-JUL-16
SAN DIEGO CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: da Vinci Xi Surgical System
Intuitive Surgical, Inc.          510(k) NO: K161271(Special)
ATTN: Brandon  Hansen             PHONE NO : 408 5237485 
1266 Kifer Road                   SE DECISION MADE: 11-JUL-16
Sunnyvale CA  94086               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cool Renewal
COOL RENEWAL, LLC                 510(k) NO: K161296(Traditional)
ATTN: ASHLEY  RAINS               PHONE NO : 615 8440132 
2515 EUGENIA AVENUE, SUITE 103    SE DECISION MADE: 06-JUL-16
NASHVILLE TN  37211               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PC ECG
EDAN INSTRUMENTS, INC.            510(k) NO: K161302(Traditional)
ATTN: ERICO  LI                   PHONE NO : 86 7552 6858736 
3/F - B, NANSHAN MEDICAL EQUIPMENTSE DECISION MADE: 01-JUL-16
SHENZHEN  CN 518067               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Habib EUS RFA 
EMCISION LTD.                     510(k) NO: K161305(Traditional)
ATTN: FRANCOIS   POULIN           PHONE NO : 1 514 9949649 
DU CANE ROAD                      SE DECISION MADE: 07-JUL-16
LONDON  GB W12 0HS                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE
FLEXICARE MEDICAL LIMITED         510(k) NO: K161314(Third Party - Traditional)
ATTN: JOEL  BIDDLE                PHONE NO : 44 144 3474560 
CYNON VALLEY BUSINESS PARK        SE DECISION MADE: 06-JUL-16
MOUNTAIN ASH  GB CF45 4ER         510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: TightRail Sub-C Rotating Dilator Sheath
Spectranetics, Inc.               510(k) NO: K161333(Traditional)
ATTN: Stephanie   Byrum           PHONE NO : 719 4472000 
9965 Federal Drive                SE DECISION MADE: 08-JUL-16
Colorado Springs CO  80921        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CryoDose H or Similar 
NUANCE MEDICAL, LLC               510(k) NO: K161337(Traditional)
ATTN: MARC  LIEBERMAN             PHONE NO : 760 5854849 
5931 Sea Lion Place, Suite 113    SE DECISION MADE: 12-JUL-16
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RadPRO® Mobile 40kW; RadPRO® Mobile 40kW FLEXPLUS, Model SM-40HF-B-D-VIR
SEDECAL SA                        510(k) NO: K161345(Special)
ATTN: Ma Luisa Gomez de Aguero    PHONE NO : 34 91 6280544 
PELAYA, 9 POL.; POL. IND. "RIO DE SE DECISION MADE: 06-JUL-16
ALGETE  ES 28110                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 6400 Ultrasound System,7400 Ultrasound System, 7410 Ultrasound System
Esaote S.p.A                      510(k) NO: K161359(Traditional)
ATTN: Massimo  Polignano          PHONE NO : 39 010 65471 
Via A. Siffredi 58                SE DECISION MADE: 19-JUL-16
Genova  IT 16153                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EVEREST Spinal System 
K2M, Incorporated                 510(k) NO: K161369(Special)
ATTN: NANCY  GIEZEN               PHONE NO : 571 9192000 
600 HOPE PARKWAY SE               SE DECISION MADE: 21-JUL-16
LEESBURG VA  20175                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LVivo Software Application
DIACARDIO, LTD.                   510(k) NO: K161382(Traditional)
ATTN: Michal  Yaacobi             PHONE NO : 972 777 648318 
HAENERGIA STREET 77               SE DECISION MADE: 28-JUL-16
Be’er Sheva  IL 8496500           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SPEC Model M13
Source Production and Equipment Co510(k) NO: K161395(Traditional)
ATTN: Kelley  Richardt            PHONE NO : 504 4649471 
113 Teal Street                   SE DECISION MADE: 06-JUL-16
Saint Rose LA  70087              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Genesys Spine Apache® Lateral Lumbar Interbody Fusion System
Genesys Spine                     510(k) NO: K161404(Special)
ATTN: Dave  Lamb                  PHONE NO : 512 3817904 
1250 Capital of Texas of Highway SSE DECISION MADE: 21-JUL-16
Austin TX  78746                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ascential IBD PEEKc Spacer
Stryker Spine                     510(k) NO: K161407(Special)
ATTN: Tina  Mornak                PHONE NO : 201 7608193 
2 Pearl Court                     SE DECISION MADE: 15-JUL-16
Allendale NJ  07401               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Multi Modality Viewer
VITAL IMAGES, INC.                510(k) NO: K161419(Traditional)
ATTN: KATIE  RYAN                 PHONE NO : 952 4879793 
5850 OPUS PARKWAY, SUITE 300      SE DECISION MADE: 13-JUL-16
MINNETONKA MN  55343-4414         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pirouette 035
ArraVasc Limited                  510(k) NO: K161427(Special)
ATTN: Aoife  Donoghue             PHONE NO : 353 91 758939 
2 Ballybrit Business Park         SE DECISION MADE: 30-JUL-16
Galway  IE                        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ekso™ (version 1.1) and Ekso GT™ (version 1.2)
EKSO BIONICS, INC.                510(k) NO: K161443(Traditional)
ATTN: Thomas   Looby              PHONE NO : 510 9841761 
1414 HARBOUR WAY SOUTH, SUITE 1201SE DECISION MADE: 19-JUL-16
RICHMOND VA  94804                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BostonSight PD Prosthetic Device
BostonSight                       510(k) NO: K161461(Traditional)
ATTN: Gene  Guselli               PHONE NO : 781 7267503 
464 Hillside Avenue, Suite 205    SE DECISION MADE: 25-JUL-16
Needham MA  02494                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VertiForm Posterior Fixation System
NEXT ORTHOSURGICAL                510(k) NO: K161499(Special)
ATTN: ELLEN  YARNALL              PHONE NO : 760 2953600 
3270 CORPORATE VIEW, SUITE A      SE DECISION MADE: 29-JUL-16
VISTA CA  92081                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cianna Medical SAVI Scout Reflector and SAVI Scout System
CIANNA MEDICAL, INC.              510(k) NO: K161507(Traditional)
ATTN: GARY   MOCNIK               PHONE NO : 949 3600059 134
6 JOURNEY SUITE 125               SE DECISION MADE: 29-JUL-16
ALISO VIEJO CA  92656             510(k) STATEMENT
                                                    

DEVICE: 3D OCT-1 Maestro
Topcon Corporation                510(k) NO: K161509(Traditional)
ATTN: Charles  Reisman            PHONE NO : 201 5995283 
75-1 Hasunuma-cho, Itabashi-ku    SE DECISION MADE: 28-JUL-16
Tokyo  JP 174-8580                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: INDIGO Aspiration System
Penumbra, Inc.                    510(k) NO: K161523(Special)
ATTN: Aditi  Kolla                PHONE NO : 510 9952010 
One Penumbra Place                SE DECISION MADE: 01-JUL-16
Alameda CA  94502                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Elect510(k) NO: K161525(Traditional)
ATTN: Wu  Zicui                   PHONE NO : 86 755 81885658 
Mindray Building, Keji 12th Road SSE DECISION MADE: 13-JUL-16
Shenzhen  CN 518057               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2; IntelliVue Patient Monitors MP20, MP30, MP40, MP50, MP60; IntelliVue Patient Monitors MP70, MP80, MP90;IntelliVue Patient Monitors MX400, MX430, MX450, MX500, MX550, MX600;IntelliVue Patient Monitors MX700, MX800     
Philips Medizin Systeme Boeblingen510(k) NO: K161531(Special)
ATTN: Markus  Stacha              PHONE NO : 49 7031 4632840 
Hewlett-Packard-Str.-2            SE DECISION MADE: 01-JUL-16
Boeblingen  DE 71034              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BD SafeAssist
BECTON, DICKINSON AND COMPANY     510(k) NO: K161553(Special)
ATTN: Meriam   Youssef            PHONE NO : 201 8476557 
1 BECTON DR                       SE DECISION MADE: 06-JUL-16
Franklin Lakes NJ  07417          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: truFreeze System
CSA MEDICAL, INC.                 510(k) NO: K161557(Traditional)
ATTN: SHERRIE  COVAL-GOLDSMITH    PHONE NO : 781 5384720 
91 HARTWELL AVENUE                SE DECISION MADE: 26-JUL-16
LEXINGTON MA  02421               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm Disposable Bipolar Ablator 55°, Non-Aspirating,  Bovie 1.8mm Disposable Bipolar Ablator 60°, Non-Aspirating               
BOVIE MEDICAL CORPORATION         510(k) NO: K161558(Traditional)
ATTN: Rubiela  Maldonado          PHONE NO : 727 8038508 
5115 ULMERTON ROAD                SE DECISION MADE: 29-JUL-16
CLEARWATER FL  33760              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Allura Xper FD series and Allura Xper OR Table series
Philips Medical Systems Nederland 510(k) NO: K161563(Traditional)
ATTN: Jeanette   Becker           PHONE NO : 31 6 11386380 
VEENPLUIS 4-6                     SE DECISION MADE: 29-JUL-16
BEST  NL 5684PC                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PASS LP Spinal System
MEDICREA INTERNATIONAL S.A.       510(k) NO: K161627(Traditional)
ATTN: DAVID  RYAN                 PHONE NO : 33 472 018787 
14 PORTE DU GRAND LYON            SE DECISION MADE: 29-JUL-16
NEYRON  FR 01700                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MAMMI
GENERAL EQUIPMENT FOR MEDICAL IMAG510(k) NO: K161631(Special)
ATTN: JOSE  MONTES                PHONE NO : 34 96 3722472 
EDUARDO PRIMO YUFERA, N 3         SE DECISION MADE: 28-JUL-16
VALENCIA  ES 46012                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Penumbra System ACE 68 Reperfusion Catheter
Penumbra, Inc.                    510(k) NO: K161640(Special)
ATTN: Charles  DeNault            PHONE NO : 510 7483302 
One Penumbra Place                SE DECISION MADE: 12-JUL-16
Alameda CA  94502                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FlexSeal Introducer Sheath with Hydrophilic Coating
LIBRA MEDICAL INC.                510(k) NO: K161659(Third Party - Traditional)
ATTN: SEW-WAH  TAY                PHONE NO : 612 8016782 
8401 73RD AVE NORTH SUITE 63      SE DECISION MADE: 15-JUL-16
MINNEAPOLIS MN  55428             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)
CONFORMIS, INC.                   510(k) NO: K161668(Special)
ATTN: AMITA  SHAH                 PHONE NO : 781 3459164 
28 CROSBY DR.                     SE DECISION MADE: 15-JUL-16
BEDFORD MA  01730                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Waterlase Express
Biolase, Inc.                     510(k) NO: K161669(Traditional)
ATTN: Alicia  Mszyca              PHONE NO : 949 2268471 
4 Cromwell                        SE DECISION MADE: 28-JUL-16
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: syngo®.via protoNeo (Version VA10A)
SIEMENS HEALTHCARE GMBH           510(k) NO: K161685(Third Party - Traditional)
ATTN: LAUREN  BENTLEY             PHONE NO : 610 4486104 
HENKESTRASSE 127                  SE DECISION MADE: 11-JUL-16
ERLANGEN  DE 91052                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Threshold™ Pedicular Fixation System
Spineology Inc.                   510(k) NO: K161694(Special)
ATTN: JACQUELINE A. HAUGE         PHONE NO : 651 2568500 
7800 3rd Street N, Suite 600      SE DECISION MADE: 15-JUL-16
St. Paul MN  55128-5455           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VITRUVIAN ULTIMATE ASPIRATOR
BLACK & BLACK SURGICAL, INC.      510(k) NO: K161722(Third Party - Traditional)
ATTN: CYNTHIA  REES               PHONE NO : 770 4144880 
5238 ROYAL WOODS PKWY, SUITE 170  SE DECISION MADE: 26-JUL-16
TUCKER GA  30084                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: E-Pack Procedure Kit
ETHICON, INC.                     510(k) NO: K161726(Special)
ATTN: ENZA  DESERIO               PHONE NO : 908 2182662 
ROUTE 22 WM P.O. BOX 151          SE DECISION MADE: 12-JUL-16
SOMERVILLE NJ  08876              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medilas H Laser Fibers
DORNIER MEDTECH AMERICA, INC.     510(k) NO: K161771(Special)
ATTN: JOHN  HOFFER                PHONE NO : 770 5146163 
1155 ROBERTS BLVD, SUITE 100      SE DECISION MADE: 28-JUL-16
KENNESAW GA  30144                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ACUSON NX2 Diagnostic Ultrasound Systems
Siemens Medical Solutions USA, Inc510(k) NO: K161787(Third Party - Traditional)
ATTN: Shelly  Pearce              PHONE NO : 650 2790134 
685 E MIDDLEFIELD RD              SE DECISION MADE: 28-JUL-16
Mountain view CA  94043           510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: CrossCath Support Catheter
Cook Incorporated                 510(k) NO: K161801(Special)
ATTN: Jessica  Swafford           PHONE NO : 812 3353575 104260
750 Daniels Way                   SE DECISION MADE: 29-JUL-16
Bloomington IN  47402             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EnCor MRI Introducer Set, EnCor Probe Introducer
SENORX, INC.                      510(k) NO: K161805(Special)
ATTN: SARAH  MCCARTNEY            PHONE NO : 480 6382954 
1625 WEST 3RD STREET              SE DECISION MADE: 19-JUL-16
TEMPE AZ  85281                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tina-quant Cystatin C Gen.2
Roche Diagnostics Operations (RDO)510(k) NO: K161817(Special)
ATTN: Patrick  Stimart            PHONE NO : 317 5213954 
9115 Hague Road                   SE DECISION MADE: 27-JUL-16
Indianapolis IN  46250            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 2D Quantitative Analysis
PHILIPS MEDICAL SYSTEMS NEDERLAND 510(k) NO: K161839(Abbreviated)
ATTN: JEANETTE  BECKER            PHONE NO : 31 611 621238 
VEENPLUIS 4-6                     SE DECISION MADE: 29-JUL-16
BEST  NL 5684PC                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bright
Tanda Beauty Canada Inc.          510(k) NO: K161849(Special)
ATTN: Bobae  Kim                  PHONE NO : 212 2452999 202
11-380 Jamieson Parkway           SE DECISION MADE: 29-JUL-16
Cambridge  CA                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve Controls
PHADIA AB                         510(k) NO: K161899(Special)
ATTN: Ulf  Karlberg               PHONE NO : 46 18 165000 
RAPSGATAN 7P                      SE DECISION MADE: 28-JUL-16
UPPSALA  SE 75137                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Comfort Cover
PRECISION DYNAMICS CORPORATION    510(k) NO: K161920(Third Party - Traditional)
ATTN: SWARNA  MUKUND              PHONE NO : 661 2570233 
27770 ENTERTAINMENT DRIVE, STE 200SE DECISION MADE: 15-JUL-16
VALENCIA CA  91355                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay
KRONUS, INC.                      510(k) NO: K161951(Special)
ATTN: Brian  Deis                 PHONE NO : 208 3774800 
170 S. SENECA SPRINGS WAY, SUITE 1SE DECISION MADE: 22-JUL-16
STAR ID  83669                    510(k) STATEMENT
                                                    


                TOTAL 510(k)s THIS PERIOD   236                                     
                TOTAL WITH SUMMARIES        220                                     
                TOTAL WITH STATEMENTS        16
                                      

Page Last Updated: 08/08/2016
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